FDAFDA · Food and drugs·Recall number Z-2329-2016
6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usage: The 6F/7F MynxGrip Vascular Closure Device is indicated for use to seal femoral arterial and femoral venous access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 6F or 7F procedural sheath. The 6F/7F MynxGrip Vascular Closure Device is designed to achieve femoral artery and femoral vein hemostasis via delivery of an extravascular, water-soluble synthetic sealant using a balloon catheter in conjunction with a standard procedural sheath. The sealant is comprised of a polyethylene glycol (PEG) material which expands upon contact with subcutaneous fluids to seal the arteriotomy or venotomy. The sealant is resorbed by the body within 30-days.
Published August 10, 2016 · Recall initiated: July 13, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- AccessClosure, Inc., A Cardinal Health Company
- Distributor
- US in the states of CA, and MS.
- Lot
- Lot No: F1609702, Expiry 4/20/2018; Lot No. F1534302, Expiry 12/31/2016
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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